ClinicalTrials.gg
Status unknownNCT05565690Updated Oct 4, 2022

Role of MRS in Brain Lesions

An observational study in Brain Lesion (General) and Mrs, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2022-10-04.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
64
Sex
All
01

Study summary

Aim of the study is evaluation of accuracy of magnetic resonance spectroscopy in differentiation between neoplastic and non neoplastic lesions and determination the type of neoplasm

Read the detailed description

The annual global age-standardized incidence of primary malignant brain tumors is \~3.7 per 100,000 for males and 2.6 per 100,000 for females . Rates appear to be higher more in developed countries (males, 5.8 and females, 4.1 per 100,000) than in less developed countries (males 3.0 and females 2.1 per 100,000). More than half of all brain tumors are Intraparenchymal . Diagnosis of brain lesions and other focal intracranial lesions based on imaging methods alone is still facing a challenging problem. Accurate diagnosis is fundamentally vital for clinical management in patients with brain tumors. CT and standard MRI are the first line imaging modalities in evaluation of brain lesions; however, it does not always provide more precise details and characterization of the lesions whether it is benign or malignant. Conventional imaging techniques do not provide exact information about vascularity, cellularity and metabolism of the mass lesion . Magnetic Resonance Spectroscopy (MR Spectroscopy) is one of the tools used to determine themolecular structures of compounds or to detect the compound presence. MR Spectroscopy provides metabolic information from living tissues. The major brain metabolites detected are choline, creatine, N-acetyl aspartate (NAA), lactate, myoinositol, glutamine, glutamate, lipids and the amino acids leucine and alanine. Brain lesions show abnormal values of these metabolites as compared to normal tissue.Our study aims to determine the accuracy of MRS in differentiation between neoplastic and non neoplastic lesions and determination the type of neoplasm, Discriminating neoplastic from non-neoplastic brain lesions is extremely necessary since a misdiagnosis can lead to a severe effect on neurosurgery and exposure to toxic chemotherapy or radiotherapy, which may cause damage to brain tissues.

02

Conditions studied

  • Brain Lesion (General)
  • Mrs
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with brain lesions of any age

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with solitary intraaxial brain lesions
  • patients with de novo lesions
  • Patient age : any age

Exclusion criteria

Exclusion Criteria:

  • patients with multiple intra-axial brain lesions
  • patients with extra-axial brain lesions
  • patients with recurrent lesions
  • patients receiving chemotherapy or radiotherapy
  • patients unfit for surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
64 participants (estimated)
Patient registry
No

Interventions

  • DeviceMRS

    It is a tool used to determine the molecular structure of compounds or to detect the compound presence , it provides metabolic information from living brain

06

What researchers measure

Primary outcomes

  1. evaluation of accuracy of magnetic resonance spectroscopy in differentiation between neoplastic and non neoplastic lesions and determination the type of neoplasm

    Analysis of the MRS metabolites peaks and test if they can differentiate between neoplastic and non neoplastic lesions and grades of neoplasm by comparison with postoperative histopathology

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2022; primary completion for Oct 2024, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 30, 2022
First posted
Oct 4, 2022
StartEst.
Oct 1, 2022
Primary completionEst.
Oct 1, 2024
CompletionEst.
Nov 1, 2024
Last update
Oct 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05565690
Lead sponsor
Assiut University
Responsible party
Ahmed Mohamed Aboelmagd Ahmed (Resident doctor, Assiut University) — Principal investigator
First posted
Oct 4, 2022
Start date
Oct 1, 2022 (estimated)
Primary completion
Oct 1, 2024 (estimated)
Completion
Nov 1, 2024 (estimated)
Last update
Oct 4, 2022

Study contacts

Ahmed Mohamed Aboelmagd, Resident doctor
Contact
ahmed.14223789@med.aun.edu.eg
01099474580
Mohamed El-Sayed Mahmoud, Professor
Contact
msmluxor@aun.edu.eg
01016077797
Ali Ahmed Abd-Elaleem, Lecturer
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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